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Vulvovaginal Atrophy clinical trials

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NCT ID: NCT03385551 Completed - Clinical trials for Vulvovaginal Atrophy

Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Start date: December 9, 2019
Phase:
Study type: Observational

This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream

NCT ID: NCT03281655 Completed - Menopause Clinical Trials

Visnadine, Prenylflavonoids and Bovine Colostrum to Treat Vulvovaginal Atrophy in Postmenopausal Women

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by vulvovaginal atrophy (VVA). In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. All women will undergo vaginal health index score (VHIS) evaluation and will complete the female sexual function index (FSFI) questionnaire at baseline evaluation (T0) and following 15 days of vaginal cream treatment with one application per day (T1). All the side effects will be recorded and an independent data safety and monitoring committee will evaluate the results of the study.

NCT ID: NCT03271944 Recruiting - Clinical trials for Vulvovaginal Atrophy

Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy

Start date: December 29, 2016
Phase: N/A
Study type: Interventional

To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal dryness by means of a visual analogic scale (10 cm VAS).

NCT ID: NCT03083262 Completed - Clinical trials for Vulvovaginal Atrophy

High Tone Pelvic Floor Dysfunction

Start date: January 31, 2017
Phase: N/A
Study type: Observational

Dyspareunia, or painful intercourse, is one of the most commonly reported complaints in postmenopausal women. One common cause of dyspareunia is vaginal atrophy (VVA), which occurs in >50% of postmenopausal women. At the time of menopause, a lack of estrogen thins the vaginal mucosa and lessons lubrication, making sex painful. Some women with vaginal atrophy will also have high tone pelvic floor dysfunction (HTPFD) (also known as levator spasm). Successful treatment of the sexual pain requires treatment of both vaginal atrophy and HTPFD. How often vaginal atrophy and HTPFD coexist has not been studied. In fact, the prevalence of HTPFD is unknown. This is most likely due to the fact that many clinicians are unaware of its existence or how to diagnose or treat it. Also, sexual symptoms tend to be underreported due to embarrassment or hesitation to seek care. HTPFD frequently coexists with other conditions that cause pain like vaginal atrophy, endometriosis or interstitial cystitis. Treatment includes treating both conditions. If only one is treated, then sexual pain is likely to continue. There are several available treatments for HTPFD that have been studied including physical therapy, botox and intravaginal diazepam. This is an area where clinicians may be under treating a condition and limiting the possibility of restoring normal sexual function to many women. Treating only vaginal atrophy without appropriate evaluation and treatment of HTPFD leaves a cohort of women still struggling with sexual pain. With a better understanding of the relationship between HTPFD and vaginal atrophy, the investigators hope to bring awareness concerning the importance of treating both in restoring normal sexual function.

NCT ID: NCT03044652 Completed - Clinical trials for Vulvovaginal Atrophy

Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol

Start date: November 2016
Phase: Phase 4
Study type: Interventional

The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream in comparison to a cream with 0.1% estriol.

NCT ID: NCT02784613 Completed - Dyspareunia Clinical Trials

Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA

Start date: July 2015
Phase: Phase 4
Study type: Interventional

This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene daily for twenty weeks. After the informed consent is signed, a baseline physical examination, and vulvoscopy with detailed photography of the vulva, vestibule and vagina, will be performed. Physical examination and vulvoscopy with detailed photography of the vulva, vestibule and vagina, will be repeated prospectively every 4 weeks for a total of 20 weeks. Therefore, physical examination and vulvoscopy with detailed photography of the vulva, vestibule and vagina will be performed prospectively at baseline (vulvoscopy session 1), 4 weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12, weeks (vulvoscopy session 4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following daily administration of 60 mg ospemifene.

NCT ID: NCT02670785 Completed - Menopause Clinical Trials

A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

Start date: February 15, 2016
Phase: Phase 2
Study type: Interventional

This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.

NCT ID: NCT02460302 Withdrawn - Menopause Clinical Trials

Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy

Start date: December 2016
Phase: Phase 2
Study type: Interventional

Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic vaginitis is caused by the decreased effect of estrogens post menopause. Traditionally, local estrogens have been used to treat atrophic vaginitis Studies have shown that there are progesterone receptors in vaginal tissues. The use of progesterone to treat atrophic vaginitis has not yet been studied. However, its use has been studied in other populations including as a fertility medication in pregnant women. There is a significant group of women who cannot use, choose not to use, or do not respond to estrogenic therapies. The goal of this study is to evaluate the efficacy of vaginal progesterone in the treatment of urogenital atrophy, compared to placebo. This study is a randomized, double-blind, placebo controlled trial. The ultimate goal is to expand the treatment options for patients with symptoms of vaginal atrophy.

NCT ID: NCT02449902 Completed - Menopause Clinical Trials

TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy

Start date: July 2013
Phase: Phase 2
Study type: Interventional

The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints. In addition, the systemic exposure to estradiol from single and multiple doses of TX-12-004-HR was to be investigated.

NCT ID: NCT02419729 Completed - Clinical trials for Vulvovaginal Atrophy

Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy

Start date: March 2015
Phase: Phase 3
Study type: Interventional

Forty-five women will be included in a double-blind randomized trial in order to compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2 laser treatment.